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FDA Reveals Alarming Lack of Diversity in Clinical Drug Trials

Did you gender and ethnicity can affect how a drug works?

The Society of Women’s Health Research (SWHR) has warned for years that female and minority participation in clinical drug trials is grievously limited. As a result, clinical trials data may give a misleading impression of a drug’s efficacy or safety for different patient populations.

That’s a serious problem for the FDA, which is responsible for approving all new drugs in the U.S. However, there are limits to how much the FDA can do about the lack of diversity. The agency does not conduct its own trials, instead relying on pharmaceutical companies to provide appropriate test data.

Six Drugs on Trial

Nonetheless, the FDA is taking an important step to at least increase the transparency of clinical trial demographics. Under a new action plan, the FDA has released six “Snapshots” of trial data for six drugs approved over a two-month period, including demographic breakdowns and locations for each clinical trial.

The FDA is seeking public feedback on the content, format and usability of these initial Snapshots. Starting next year, the agency hopes to publicly release similar data for each new molecular entity or original biologic the FDA approves.

The move to greater transparency is a start, but the SWHR cautions that the information the FDA is releasing just outlines the extent of the problem. “I am pleased by this action step by FDA,” says SWHR President and CEO Phyllis Greenberger, “but the news is discouraging. The data validates the concern we have expressed to the FDA for 25 years.”

Nonetheless, she sees the FDA’s current initiative as “an opportunity to change the way clinical trials in drugs and devices are conducted,” something the SWHR believes is long overdue. “It is time to dismiss ‘one size fits all,’” Greenberger says.

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SIdebar: Women are Not Just Smaller MenHow gender, race and weight can impact drug effectiveness

The call for more diverse clinical drug trials is not just about egalitarianism: Differences in sex and race can have a dramatic effect on a drug’s effectiveness in ways that aren’t always easy to extrapolate based on test data gathered from only white male subjects. AMBIEN. In 2013, the FDA issued new gender-specific dosing recommendations for the anti-insomnia drug zolpidem (the active ingredient in Ambien) after discovering that men’s bodies metabolize and eliminate the drug more quickly than do women’s. The previous “one size fits all” dose would often leave women too impaired to drive the following morning.

WARFARIN. A 2004 study in the Journal of Heart Valve Disease on the antithrombotic medication warfarin noted “profound” differences in efficacy for patients of different racial and ethnic backgrounds, potentially contributing to “serious or life-threatening adverse events.”

MORNING-AFTER PILL. Body weight is another often overlooked factor in clinical testing. In late 2013, the FDA launched a reevaluation of emergency contraceptives after the pharmaceutical company HRA Pharma warned that its European-market morning-after pill may not work at all for women with a body weight of more than 176 pounds, a risk that’s not listed on current U.S. labels for similar drugs.